Cleared Traditional

ZENEX MEDICAL, INC. GAUZE SPONGES (K864298) - FDA 510(k) Clearance

K864298 · Zenex Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
34d
Days
-
Risk

K864298 is an FDA 510(k) clearance for the ZENEX MEDICAL, INC. GAUZE SPONGES. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Zenex Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zenex Medical, Inc. devices

Submission Details

510(k) Number K864298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date December 04, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFQ Gauze/sponge, Internal
Device Class -